UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036532 |
|---|---|
| Receipt number | R000041613 |
| Scientific Title | Study aimed at establishment of clinical diagnostic criteria and guideline by using a multicenter registry of patients with IgG4-related disease |
| Date of disclosure of the study information | 2019/07/27 |
| Last modified on | 2023/10/24 21:56:32 |
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Basic information
Public title
Study aimed at establishment of clinical diagnostic criteria and guideline by using a multicenter registry of patients with IgG4-related disease
Acronym
Registry-based study in IgG4 -related disease
Scientific Title
Study aimed at establishment of clinical diagnostic criteria and guideline by using a multicenter registry of patients with IgG4-related disease
Scientific Title:Acronym
Registry-based study in IgG4 -related disease
Region
| Japan |
Condition
Condition
IgG4-related disease
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Ophthalmology | Oto-rhino-laryngology |
| Urology | Radiology | Neurosurgery |
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify natural history and prognostic factor of IgG4-related disease by consistent and long-term investigation based on a patients registry.
Basic objectives2
Others
Basic objectives -Others
Elucidating prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of mortality, relapse, and cancer development in IgG4-related disease.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed as definite, probable and possible IgG4-related disease according to comprehensive diagnostic criteria.
2. Patients who agree about informed consent concerning this study.
Key exclusion criteria
1. Patients in whom similar disease (cancer, Sjogren's syndrome, primary sclerosing cholangitis, Castleman's disease, secondary retroperitoneal fibrosis, Wegener's granulomatosis, sarcoidosis, Churg-Strauss syndrome) cannot be ruled out.
2. Patients who be regarded as inadequate subjects by researchers.
Target sample size
9999
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kawano |
Organization
Kanazawa University Hospital
Division name
Department of Nephrology and Rheumatology
Zip code
920-8641
Address
13-1, Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2253
igg4@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Mizushima |
Organization
Kanazawa University Hospital
Division name
Department of Nephrology and Rheumatology
Zip code
920-8641
Address
13-1, Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2253
Homepage URL
igg4@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare (Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Facility of medicine, Kyoto Uniiversity Hospital , Ethics Committe
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2034 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The data collected in this study are shared with Rare Disease Data Registry of Japan supported by Japan Agency for Medical Research and Development (AMED).
Management information
Registered date
| 2019 | Year | 04 | Month | 17 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041613
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/11/11 | IgG4レジストリ研究_20231109(まとめ).xlsx |
